FDA Inspection
Summit Medical Products, Inc.Summit Medical Products, Inc. – FDA Inspection, May 10, 2013
Record Details
This FDA Inspection record concerns Summit Medical Products, Inc., with an inspection on May 10, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 10, 2013
- Product Type
- Devices
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ID · 6d8709af-d7dd-4604-b4c8-9f2e074d0de0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 831196
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Summit Medical Products, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 24, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Summit Medical Products, Inc.
- FDA Inspection 994518 - 2016-12-12
- FDA Inspection 682386 - 2010-09-24
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